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The idea of recording patient information electronically instead of on paper –the Electronic Medical Record (EMR) –has been around since the late 1960’s, when Larry

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

Weed introduced the concept of the Problem Oriented Medical Record into medical practice. Until then, doctor’s usually recorded only their diagnoses and the treatm

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ent they provided. Weed’s innovation was to generate a record that would allow a third party to independently verify the diagnosis.

In 1972, the Regenstein Institu

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

te the Indiana University School of Medicine, developed the first medical records system. Although the concept was widely hailed as a major advance in medical prac

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ice, physicians did not fly into the technology (http://www.medrecinst.com/uploadedFiles/MRILibrary/StatusReport.pdf). In 1991, the Institute of Medicine in the US

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

recommended that by the year 2000, every physician should be using computers in their practice to improve patient care and made policy recommendations on how to ach

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ieve that goal (http://www.medinfo.ufl.edu/omi/docs/olmr/cpri.html).

However, it is estimated that EMR use is about 20% in the hospital sector in the US (less in C

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nada) and about 5% in clinics (probably about the same in Canada). Some studies report the major barriers to widespread EMR implementation. They analyze different

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

criteria, among which the major ones are: the cost of EMR purchase; the adaptation time; the length of a patient encounter; the time required to record the encount

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

er, etc.

Here are some data findings:
- Most patient encounters last about 7-10 minutes
- Typically 25% of the time is spent in documentation
- Phys

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

cians record an encounter in about 2 minutes
- current methods of data input are slow and tedious
- They need systems which are easy to use and which don’

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

t require long learning curves
- Given current costs of about $10-20K per year, there is a long way to go to get to an acceptable price
- Inability to rec

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

oup investments in technology.

It appears that market suppliers do not make a distinction between physician needs and health care system needs. Although we expect

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

that the two markets are likely to move alongside, they are different and distinct markets. Major customers for EMRs that are being developed with large amount of f

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

nctionality and complicated methods of data input will not be physicians as they are only small beneficiaries of these systems. These current systems are about wha

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

t to do, but not about what patient information is most relevant, what providers need to know to deliver good care.

The on-demand systems such as EMRian http://emr

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ian.com aim to solve the above issues, by providing 1) Low Total Cost of Ownership TCO (you pay for the features you need); 2) Simple and comprehensive data input s

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

stem; 3) No initial capital investment and no maintenance and upgrade fees.

About EMRian
EMRian http://emrian.com is a convenient on-line solution for general

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

practitioners, small medical practices and private clinics that need to manage their health practice efficiently. EMRian is a multi-function and multi-purpose int

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

eractive web-based medical records service suite for doctors. The current basic version is provided free, although premium features will be added in the near future

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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